Clinical TrialJun 8, 2026, 06:01 AM
Anteris Technologies Gets French Clearance for DurAVR® THV Pivotal Trial
AI Summary
Anteris Technologies Global Corp. announced it has received full regulatory clearance from the French National Agency for Medicines and Health Products Safety (ANSM) for its DurAVR® Transcatheter Heart Valve (THV) global pivotal trial, known as the PARADIGM Trial. This authorization allows patient recruitment to begin in France, a strategically important market. The PARADIGM Trial is a randomized controlled study comparing DurAVR® THV to existing TAVRs in approximately 1,000 patients with severe calcific aortic stenosis, assessing non-inferiority on a composite endpoint at one year.
Key Highlights
- Anteris Technologies received full regulatory clearance from ANSM for the DurAVR® THV global pivotal trial.
- The PARADIGM Trial will evaluate the DurAVR® Transcatheter Heart Valve in patients with severe calcific aortic stenosis.
- Patient recruitment for the PARADIGM Trial can now commence at leading centers in France.
- The trial is a prospective randomized controlled trial comparing DurAVR® THV to commercially available TAVRs.
- Approximately 1,000 patients will be enrolled in the 'All Comers Randomized Cohort' with 1:1 randomization.
- The primary composite endpoint will assess all-cause mortality, all stroke, and cardiovascular hospitalization at one year.
- Anteris continues site activations and patient enrollment across the United States and Europe.
- The DurAVR® THV is the first biomimetic valve, designed to mimic a healthy human aortic valve.
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